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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA-II BLADE L90 TAN ROD, FIXATION, INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH PFNA-II BLADE L90 TAN ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.027.053S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Itching Sensation (1943); Pain (1994); Burning Sensation (2146); Discomfort (2330)
Event Type  Injury  
Manufacturer Narrative
Implanted on an unknown date in 2010. Complainant part is not expected to be returned for manufacturer review/investigation. Reporter is synthes employee. (510k): device is not distributed in the united states, but is similar to device marketed in the usa. A review of the device history records has been requested. The investigation could not be completed; no conclusion could be drawn, as no product was received. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Device report from synthes reports an event in (b)(6) as follows: the patient had the initial surgery on an unknown date in 2010; the patient originally underwent an implantation of proximal femoral nail antirotation (pfna-ii) blade titanium alloy (tan), pfna-ii small length nail and pfna-ii end cap extension. The patient was discharged on (b)(6) 2010 to a local residence with home health care. The patient was allowed to travel by air with the surgeon¿s permission on (b)(6) 2011 (it appears that the patient had the initial surgery at another city and was returning to her residence). It was noted that the patient "was" felt a sensation of itching and burning all along the area of surgical operation of the hip joint and the patient had discomfort/pain. Doctors were not able to identify the cause of the burning and itching or pain. The long undiagnosed treatment gave birth to more complications in the body. The reporter alleged that the cause of the itching and burning sensation and pain/ discomfort was a defective metallic implant (j&j). The patient was seen by multiple specialists and multiple unsuccessful efforts were attempted to soothe and calm the patient. There is no documentation available at what treatments were provided or medical assessments by the specialist. Suffering in pain, the patient died in hospital on (b)(6) 2012. This report is for one (1) pfna-ii blade l90 tan. This is report 1 of 3 for complaint (b)(4).
 
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Brand NamePFNA-II BLADE L90 TAN
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK BETTLACH (CH)
muracherstrasse 3
bettlach 2544
SZ 2544
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6103142063
MDR Report Key8065270
MDR Text Key126974473
Report Number8030965-2018-58148
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/01/2020
Device Catalogue Number04.027.053S
Device Lot Number2651841
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/04/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/06/2010
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 11/13/2018 Patient Sequence Number: 1
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